|
Drug Makers Near Old Goal:
A Legal Shield
GARDINER HARRIS and ALEX BERENSON
NY
Times
Monday, April 7, 2008
For years, Johnson & Johnson obscured evidence
that its popular Ortho Evra birth control patch delivered much
more estrogen than standard birth control pills, potentially increasing
the risk of blood clots and strokes, according to internal company
documents.
But because the Food and Drug Administration approved the patch,
the company is arguing in court that it cannot be sued by women
who claim that they were injured by the product — even though
its old label inaccurately described the amount of estrogen it
released.
This legal argument is called pre-emption. After decades of being
dismissed by courts, the tactic now appears to be on the verge
of success, lawyers for plaintiffs and drug companies say.
(Article continues below)
The Bush administration has argued strongly in favor of the doctrine,
which holds that the F.D.A. is the only agency with enough expertise
to regulate drug makers and that its decisions should not be second-guessed
by courts. The Supreme Court is to rule on a case next term that
could make pre-emption a legal standard for drug cases. The court
already ruled in February that many suits against the makers of
medical devices like pacemakers are pre-empted.
More than 3,000 women and their families have sued Johnson &
Johnson, asserting that users of the Ortho Evra patch suffered
heart attacks, strokes and, in 40 cases, death. From 2002 to 2006,
the food and drug agency received reports of at least 50 deaths
associated with the drug.
Documents and e-mail messages from Johnson & Johnson, made
public as part of the lawsuits against the company, show that
even before the drug agency approved the product in 2001, the
company’s own researchers found that the patch delivered
far more estrogen each day than low-dose pills. When it reported
the results publicly, the company reduced the numbers by 40 percent.
The F.D.A. did not warn the public of the potential risks until
November 2005 — six years after the company’s own
study showed the high estrogen releases. At that point, the product’s
label was changed, and prescriptions fell 80 percent, to 187,000
by last February from 900,000 in March 2004.
Gloria Vanderham, a Johnson & Johnson spokeswoman, said the
company acted responsibly.
Full
article here.
|
INFOWARS:
BECAUSE THERE'S A WAR ON FOR YOUR MIND
|
|
